Identity
- Trade Name
- Mask DSPS®-PROS, set/5 EUDAMEDFDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- DSPS-Prominent EUDAMEDDSPS Prominent Mask Set Supine, head and shoulder, set of 5 FDA UDI
- Model / Reference
- 113960 EUDAMEDDSPS-PROS FDA UDI
- Description
- DSPS Prominent Mask Set Supine, head and shoulder, set of 5 FDA UDI
Identifiers
- Catalog Number
- 113960 FDA UDI
- Primary DI / UDI-DI
- 08720168162205 EUDAMEDFDA UDI
- Basic UDI-DI
- 872016816113000GT EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011285 PATIENT POSITIONING INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Patient positioning thermoplastic mould material
Mask DSPS®-PROS, set/5 by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI 7528bc4e-a859-4c81-9d34-b95e0ca65621 34 fields · synced Jul 11, 2026
- EUDAMED 7a69c43e-7350-4c03-8b10-f01a25456867 61 fields · synced Jul 11, 2026